The Addition of Whole Grains to the Diets of Middle-school Children
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|ClinicalTrials.gov Identifier: NCT01094652|
Recruitment Status : Completed
First Posted : March 29, 2010
Last Update Posted : August 2, 2012
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Dietary Supplement: Whole grain diet Dietary Supplement: Refined grain diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||83 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||The Addition of Whole Grains to the Diets of Middle-school Children: A Study of Digestive Health and Immune Defenses|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||April 2010|
Experimental: Whole grain diet
Participants in this group will be given whole grain snacks on school days and food packages consisting of whole grain breads, breakfast cereals, rice, snack foods, and pasta to replace their typical grains consumed at home.
Dietary Supplement: Whole grain diet
Subjects were told to consume three different kinds of study food each day. The goal was an intake of greater than or equal to 80 g of whole grains per day.
Active Comparator: Refined grain diet
Participants in this group will be given refined grain snacks on school days and food packages consisting of refined grain breads, breakfast cereals, rice, snack foods, and pasta to replace their typical grains consumed at home.
Dietary Supplement: Refined grain diet
The refined grain food products were matched as closely as possible to the foods contained in the whole grain diet. Subjects were told to consume three different kinds of study food each day.
- Stool frequency [ Time Frame: 6 weeks ]
- Changes in overall microbiota diversity [ Time Frame: 6 weeks ]Microbial diversity will be measured by DGGE profiling to detect large distortions. Quantitative changes in the proportions of select bacteria will be measured using qPCR.
- Inflammatory markers [ Time Frame: 6 weeks ]Serum CRP, fibrinogen, IL-1, IL-6, and antioxidant capacity; mitogen-induced cytokine production including Th1, Th2, and inflammatory cytokines
- Secretory IgA [ Time Frame: 6 weeks ]Salivary and fecal sIgA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01094652
|United States, Florida|
|Westwood Middle School|
|Gainesville, Florida, United States, 32605|
|Principal Investigator:||Bobbi Langkamp-Henken, PhD, RD||University of Florida|